MAUDE Adverse Event Report: THERAKOS CELLEX PHOTOPHERESIS SYSTEM

Model Number NOT APPLICABLE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Chest Pain (1776)

Event Date 10/08/2019

Event Type  Injury  

Manufacturer Narrative

The system was used for treatment.This case is reportable as a mdr due to the medical intervention for the removal of the patient's clot and catheter.Since this event is associated with the treatment, this mdr will be against the instrument.From the instrument perspective, there was no known instrument malfunction and no instrument issue was alleged by the customer.No product was returned therefore, a device service history review was performed.The instrument has been located at the customer's site since (b)(6) 2014.As part of the review, it was determined that the instrument's last service prior to the event was on (b)(6) 2019.During this service the system checkout procedure was successfully completed indicating that the instrument had passed all tests, met all specifications, and was operational.Service was dispatched for this instrument.The service technician checked the centrifuge chamber's leak strip, the bowl optic sensor, all of the instrument's pump heads, and all of the instrument's air detectors.All of these items were found to be within specifications.The service technician also verified all the instrument's pump calibrations which were all found to be within specifications.During this service the system checkout procedure was successfully completed indicating that the instrument had passed all tests, met all specifications, and was operational.There were no issues found with the instrument.Trends were reviewed for complaint categories, clot observed and chest pain.No trends were detected for these complaint categories.The assessment is based on information available at the time of the investigation.Complaints are monitored through tracking and trending.If a trend is detected, further investigation will be conducted.Adverse event terms: chest pain.(b)(4).

Event Description

The customer reported that an extracorporeal photopheresis (ecp) patient experienced chest pain during a treatment procedure.The customer stated that no specific issues occurred during the patient's ecp treatment procedure, but at about 437ml of whole blood processed the patient started complaining of chest pain.The customer reported that they contacted the physician who ordered the patient's ecp treatment procedure to be aborted without blood return to the patient.The customer stated that the patient was stable however; the patient was sent for both a chest x-ray and an ekg.The customer reported that both of these tests came back negative.The customer stated that the hospital's interventional radiology (ir) team then examined the patient.The customer reported that the ir team scanned the patient's port and found a small clot.The customer reported that they extracted the clot from the patient's port and then decided to remove the patient's central venous catheter line altogether.The customer stated that they were unsure if the patient's chest pain and clot could be due to the instrument.The customer reported that the patient was stable and went home on the same day.The customer requested that a service team be dispatched to evaluate the instrument.No product was returned for investigation.

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS; bedminster NJ
• Manufacturer (Section G): MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED; college business & tech park; cruiserath road; blanchardstown, dublin, D15 T X2V; EI D15 TX2V
• Manufacturer Contact: megan vernak ; 1425 us route 206; bedminster, NJ 07921
• MDR Report Key: 9293199
• MDR Text Key: 185184603
• Report Number: 2523595-2019-00144
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CELLEX
• Device Lot Number: NOT APPLICABLE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/08/2019
• Initial Date FDA Received: 11/07/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/20/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 41 YR